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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03465865
Other study ID # ILMflap
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 1, 2017
Est. completion date December 31, 2024

Study information

Verified date June 2024
Source Vienna Institute for Research in Ocular Surgery
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

ILM-flap (internal limiting Membrane-flap) transposition is a new surgical option in repair of macular holes, therefore one year outcomes are needed to better evaluate that method.


Description:

Patients that have been scheduled for vitrectomy with ILM-flap transposition, a new surgical option in repair of macular holes, are invited to a follow-up one year after surgery, including optical coherence tomography and visual acuity testing.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - history of ILM-flap transposition Exclusion Criteria: - none

Study Design


Related Conditions & MeSH terms


Intervention

Device:
optical coherence tomography
optical coherence tomography enables diagosis of macular structures and therefore provides information on macular hole closure.

Locations

Country Name City State
Austria VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital Vienna

Sponsors (1)

Lead Sponsor Collaborator
Vienna Institute for Research in Ocular Surgery

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary OCT macular hole closure is assessed with optical coherence tomography 5 minutes
Secondary visual acuity visual acuity describes functional outcomes of the eye 5 minutes
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